The FDA has issued the first Emergency Use Authorization for a device to help treat COVID-19 patients currently in the ICU. Terumo BCT’s Spectra Optia Apheresis System, combined with Marker Therapeutics’ D2000 Adsorption Cartridge, is now indicated for adult patients with COVID-19 udergoing respiratory failure.
The device is intended to lower the levels of cytokines and other proteins in blood that promote inflammation, hopefully thereby mitigating some of the terrible consequences of the infection. These can include shock, lung failure, other organ failure and result in death.
“We thank the Food and Drug Administration for their expedited review, which provides another treatment option for patients in the ICU to help reduce the severity of the disease,” said Antoinette Gawin, CEO and President of Terumo BCT, and David Cohen, Chairman of Marker, in a joint press release published by their companies.
“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D, in a separate announcement. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”
Product page: Spectra Optia Apheresis System